Senior Manager, Biologics Analytical Development (Bioassay) (Biologics)

Location: Remote within the United States

Salary: $150,034–$224,250 per year, plus incentive opportunity

Company

hirify.global is a pharmaceutical company developing and commercializing healthcare products, including biologics.

What you will do

• Develop, optimize, qualify, and validate cell-based potency and ligand-binding bioassays.
• Manage assay robustness, method transfer, comparability, and lifecycle activities from early development through commercial manufacturing.
• Provide scientific oversight as a bioassay subject matter expert on cross-functional biologics development teams.
• Contribute technical input to CMC, Regulatory, Quality, and Process Development activities, including IND, BLA/MAA, and post-approval submissions.
• Author, review, and approve development reports, protocols, validation reports, and regulatory documents.
• Oversee internal and outsourced method transfers and bioassay activities with QC laboratories, CDMOs, and CROs.

Requirements

• PhD in Biology, Biochemistry, Immunology, Bioengineering, or a related discipline.
• 8–10+ years of analytical development experience for biologics, with a strong focus on bioassay development.
• Leadership experience managing scientific teams and supporting biologics development and regulatory submissions.
• Hands-on and theoretical expertise in cell-based assays, including reporter gene, proliferation, cytotoxicity, and signaling assays.
• Experience with ligand-binding assays and platforms such as ELISA, MSD, ECL, SPR, and flow cytometry, as well as potency assay design, qualification, and validation.
• Understanding of ICH, USP, FDA, and EMA expectations, plus GLP, GMP, and data integrity requirements.

Culture & Benefits

• Remote work arrangement for the United States-based role.
• Medical, dental, vision, and prescription drug coverage.
• Company-provided life and disability insurance.
• Tuition reimbursement and student loan assistance.
• 401(k) match, flexible time off, paid holidays, and paid leave programs.